A Study to Evaluate CNTO 1959 in the Treatment of Patient... | NCT01483599

ID	Type	Description	Link
CNTO1959PSO2001	Other Identifier	Janssen Inc.
2011-001066-17	EudraCT Number

Label	Type	Description	Intervention Names
CNTO 1959 (5 mg)	Experimental	CNTO 1959 5 mg at weeks 0, 4, and 16, then every 12 weeks through Week 40	Drug: CNTO 1959 (5 mg)
CNTO 1959 (15 mg)	Experimental	CNTO 1959 15 mg at weeks 0, 8, and 16, then every 8 weeks through Week 40	Drug: CNTO 1959 (15 mg)
CNTO 1959 (50 mg)	Experimental	CNTO 1959 50 mg at weeks 0, 4, and 16, then every 12 weeks through Week 40	Drug: CNTO 1959 (50 mg)
CNTO 1959 (100 mg)	Experimental	CNTO 1959 100 mg at weeks 0, 8, and 16, then every 8 weeks through Week 40	Drug: CNTO 1959 (100 mg)
CNTO 1959 (200 mg)	Experimental	CNTO 1959 200 mg at weeks 0, 4, and 16, then every 12 weeks through Week 40	Drug: CNTO 1959 (200 mg)
Adalimumab (approved psoriasis dosing)	Active Comparator

Name	Type	Description	Arm Group Labels	Other Names
CNTO 1959 (5 mg)	Drug	Subcutaneous (SC) injections	CNTO 1959 (5 mg)

Measure	Description	Time Frame
Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 16	PGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. Lesions were graded as erythema [0 (no evidence of plaque) to 5 (dusky to deep red coloration)], induration [0 (no plaque evaluation) to 5 (marked plaque evaluation)] and scaling [0 (no evidence of scaling) to 5 (severe; very thick tenacious scaling)]. The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0= cleared; 1= minimal; 2= mild; 3= moderate; 4= marked and 5= severe).	Week 16

Measure	Description	Time Frame
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16	The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of plaque-type psoriasis with or without psoriatic arthritis for at least 6 months prior to first administration of any study agent
Must be a candidate for phototherapy or systemic treatment for psoriasis (either new to treatment or having had previous treatment)
Must be considered, in the opinion of the investigator, suitable candidates for adalimumab therapy
If a woman, she must be postmenopausal, or if premenopausal, she must be either surgically sterile, practicing a highly effective method of birth control, or not heterosexually active during the study and for 5 months after receiving the last dose of study drug
If a man, he must agree to use a double-barrier method of birth control (or must have been surgically sterilized) and to not donate sperm during the study and for 5 months after receiving the last dose of study drug.

Exclusion Criteria:

History of or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
Has a contra-indication to anti-TNF therapy
Has a history of chronic or recurrent infectious disease
Has a nonplaque form of psoriasis or has drug-induced psoriasis
Has been previously treated with adalimumab
Has received any therapeutic agent directly targeted to IL-12, IL-17, or IL-23, (including but not limited to ustekinumab, briakinumab [ABT-874], AIN457, and SCH900222) within 6 months of the first administration of study agent.

Name	Affiliation	Role
Janssen Inc. Clinical Trial	Janssen Inc.	Study Director

PubMed Identifier	Type	Citation	Retractions
37906417	Derived	Strober B, Coates LC, Lebwohl MG, Deodhar A, Leibowitz E, Rowland K, Kollmeier AP, Miller M, Wang Y, Li S, Chakravarty SD, Chan D, Shawi M, Yang YW, Thaҫi D, Rahman P. Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis. Drug Saf. 2024 Jan;47(1):39-57. doi: 10.1007/s40264-023-01361-w. Epub 2023 Oct 31.
26154787

ID	Title	Description
FG000	Placebo (CP)	Participants received placebo matched to CNTO1959 subcutaneous injection at Week 0, Week 4 and Week 8.
FG001	CNTO1959 5 mg (CP)	Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 16

PGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. Lesions were graded as erythema [0 (no evidence of plaque) to 5 (dusky to deep red coloration)], induration [0 (no plaque evaluation) to 5 (marked plaque evaluation)] and scaling [0 (no evidence of scaling) to 5 (severe; very thick tenacious scaling)]. The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0= cleared; 1= minimal; 2= mild; 3= moderate; 4= marked and 5= severe).

Population analyzed included all participants who were randomized.

Posted

Number

percentage of participants

Week 16

ID	Title	Description
OG000	Placebo	Participants received placebo matched to CNTO1959 subcutaneous injection at Week 0, Week 4, Week 8 then 100 mg CNTO1959 at Week 16 and once every 8 weeks thereafter through Week 40.
OG001	CNTO1959 5 mg	Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
OG002	CNTO1959 15 mg	Participants received CNTO1959 15 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
OG003	CNTO1959 50 mg	Participants received CNTO1959 50 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
OG004	CNTO1959 100 mg	Participants received CNTO1959 100 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
OG005	CNTO1959 200 mg	Participants received CNTO1959 200 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
OG006	Adalimumab	Participants received Adalimumab 80 mg subcutaneous injection at Week 0, 40 mg at Week 1 and once every other week thereafter through Week 39.

Units	Counts
Participants	OG00042 OG00141 OG00241 OG003

Title

Denominators

Categories

Title	Measurements
	OG0007.1 OG00134.1 OG00261.0 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (less than or equal to (<=) 90 kilogram (kg), greater than (>) 90 kg).	Cochran-Mantel-Haenszel chi-square test		0.002														Superiority or Other
OG000 OG002	p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (<=90 kg, >90 kg).

Secondary

Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline.

Population analyzed included all participants who were randomized.

Posted

Number

percentage of participants

Week 16

ID	Title	Description
OG000	Placebo	Participants received placebo matched to CNTO1959 subcutaneous injection at Week 0, Week 4, Week 8 then 100 mg CNTO1959 at Week 16 and once every 8 weeks thereafter through Week 40.
OG001	CNTO1959 5 mg	Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
OG002

Secondary

Difference in Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) in CNTO1959 Groups Compared With Adalimumab Group at Week 16

Population analyzed included all participants who were randomized.

Posted

Number

percentage of participants

Week 16

ID	Title	Description
OG000	CNTO1959 5 mg	Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
OG001	CNTO1959 15 mg	Participants received CNTO1959 15 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
OG002	CNTO1959 50 mg

Secondary

Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 40

Population analyzed included all participants who were randomized. Here, 'Number of participants analyzed' signifies those participants who were evaluable for this outcome measure. The placebo reporting group was not planned to be analyzed in this outcome measure.

Posted

Number

percentage of participants

Week 40

ID	Title	Description
OG000	CNTO1959 5 mg	Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
OG001	CNTO1959 15 mg	Participants received CNTO1959 15 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.

Secondary

Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16

The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.

Population analyzed included all participants who were randomized. Here, 'Number of participants analyzed' signifies those participants who were evaluable for this outcome measure.

Posted

Mean

Standard Deviation

units on a scale

Baseline and Week 16

ID	Title	Description
OG000	Placebo	Participants received placebo matched to CNTO1959 subcutaneous injection at Week 0, Week 4, Week 8 then 100 mg CNTO1959 at Week 16 and once every 8 weeks thereafter through Week 40.
OG001	CNTO1959 5 mg	Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo (CP)	Participants received placebo matched to CNTO1959 subcutaneous injection at Week 0, Week 4 and Week 8.	1	42	13	42
EG001	CNTO1959 5 mg (CP)	Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8.	0	41	15	41
EG002	CNTO1959 15 mg (CP)	Participants received CNTO1959 15 mg subcutaneous injection at Week 0 and Week 8 and matching placebo subcutaneous injection at Week 4.	0	41	10	41
EG003	CNTO1959 50 mg (CP)	Participants received CNTO1959 50 mg subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8.	3	42	10	42
EG004	CNTO1959 100 mg (CP)	Participants received CNTO1959 100 mg subcutaneous injection at Week 0 and Week 8 and matching placebo subcutaneous injection at Week 4.	0	42	7	42
EG005	CNTO1959 200 mg (CP)	Participants received CNTO1959 200 mg subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8.	0	41	8	41
EG006	Adalimumab (CP)	Participants received Adalimumab 80 mg subcutaneous injection at Week 0 and 40 mg at Week 1 and every other week up to Week 15.	1	43	10	43
EG007	Placebo -> 100 mg CNTO1959 (After CP)	Same participants who received placebo and completed controlled period transitioned to receive 100 mg CNTO1959 at Week 16 and once in every 8 weeks through Week 40.	0	39	16	39
EG008	CNTO1959 5 mg (After CP)	Participants who received CNTO1959 5 mg and completed controlled period continued to receive CNTO1959 5 mg starting at Week 16 and once in every 12 weeks through Week 40.	2	38	12	38
EG009	CNTO1959 15 mg (After CP)	Participants who received CNTO1959 15 mg and completed controlled period continued to receive CNTO1959 15 mg starting at Week 16 and once in every 8 weeks through Week 40.	0	41	4	41
EG010	CNTO1959 50 mg (After CP)	Participants who received CNTO1959 50 mg and completed controlled period continued to receive CNTO1959 50 mg starting at Week 16 and once in every 12 weeks through Week 40.	0	39	11	39
EG011	CNTO1959 100 mg (After CP)	Participants who received CNTO1959 100 mg and completed controlled period continued to receive CNTO1959 100 mg starting at Week 16 and once in every 8 weeks through Week 40.	2	40	16	40
EG012	CNTO1959 200 mg (After CP)	Participants who received CNTO1959 200 mg and completed controlled period continued to receive CNTO1959 200 mg starting at Week 16 and once in every 12 weeks through Week 40.	0	38	12	38
EG013	Adalimumab (After CP)	Participants who received adalimumab and completed controlled period continued to receive adalimumab 40 mg starting at week 17 and every other week thereafter through Week 39.	1	38	13	38

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Atrial Flutter	Cardiac disorders	MedDRA Version 16.0	Non-systematic Assessment	EG0000 affected42 at risk EG0010 affected41 at risk EG0020 affected41 at risk EG0030 affected42 at risk EG0040 affected42 at risk EG0050 affected41 at risk EG0061 affected43 at risk EG0070 affected39 at risk EG0080 affected38 at risk EG0090 affected41 at risk EG0100 affected39 at risk EG0110 affected40 at risk EG0120 affected38 at risk EG0130 affected38 at risk
Myocardial Infarction	Cardiac disorders	MedDRA Version 16.0	Non-systematic Assessment	EG0000 affected42 at risk EG0010 affected41 at risk EG0020 affected41 at risk EG003
Oesophagitis Haemorrhagic	Gastrointestinal disorders	MedDRA Version 16.0	Non-systematic Assessment	EG0000 affected42 at risk EG0010 affected41 at risk EG0020 affected41 at risk EG003
Umbilical Hernia	Gastrointestinal disorders	MedDRA Version 16.0	Non-systematic Assessment	EG0000 affected42 at risk EG0010 affected41 at risk EG0020 affected41 at risk EG003
Appendicitis	Infections and infestations	MedDRA Version 16.0	Non-systematic Assessment	EG0000 affected42 at risk EG0010 affected41 at risk EG0020 affected41 at risk EG003
Lung Abscess	Infections and infestations	MedDRA Version 16.0	Non-systematic Assessment	EG0000 affected42 at risk EG0010 affected41 at risk EG0020 affected41 at risk EG003
Pneumonia	Infections and infestations	MedDRA Version 16.0	Non-systematic Assessment	EG0000 affected42 at risk EG0010 affected41 at risk EG0020 affected41 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA Version 16.0	Non-systematic Assessment	EG0000 affected42 at risk EG0010 affected41 at risk EG0020 affected41 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 16.0	Non-systematic Assessment	EG0000 affected42 at risk EG0010 affected41 at risk EG0020 affected41 at risk EG003
Cerebrovascular Accident	Nervous system disorders	MedDRA Version 16.0	Non-systematic Assessment	EG0000 affected42 at risk EG0010 affected41 at risk EG0020 affected41 at risk EG003
Uterine Prolapse	Reproductive system and breast disorders	MedDRA Version 16.0	Non-systematic Assessment	EG0001 affected42 at risk EG0010 affected41 at risk EG0020 affected41 at risk EG003
Haematoma	Vascular disorders	MedDRA Version 16.0	Non-systematic Assessment	EG0000 affected42 at risk EG0010 affected41 at risk EG0020 affected41 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Fatigue	General disorders	MedDRA Version 16.0	Non-systematic Assessment	EG0003 affected42 at risk EG0011 affected41 at risk EG0021 affected41 at risk EG0032 affected42 at risk EG0040 affected42 at risk EG0050 affected41 at risk EG0060 affected43 at risk EG0070 affected39 at risk EG0080 affected38 at risk EG0090 affected41 at risk EG0100 affected39 at risk EG0110 affected40 at risk EG0121 affected38 at risk EG0130 affected38 at risk
Influenza Like Illness	General disorders	MedDRA Version 16.0	Non-systematic Assessment	EG0000 affected42 at risk EG0010 affected41 at risk EG0021 affected41 at risk EG003
Injection Site Erythema	General disorders	MedDRA Version 16.0	Non-systematic Assessment	EG0001 affected42 at risk EG0010 affected41 at risk EG0020 affected41 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA Version 16.0	Non-systematic Assessment	EG0000 affected42 at risk EG0011 affected41 at risk EG0021 affected41 at risk EG003
Influenza	Infections and infestations	MedDRA Version 16.0	Non-systematic Assessment	EG0000 affected42 at risk EG0010 affected41 at risk EG0021 affected41 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA Version 16.0	Non-systematic Assessment	EG0001 affected42 at risk EG0016 affected41 at risk EG0024 affected41 at risk EG003
Sinusitis	Infections and infestations	MedDRA Version 16.0	Non-systematic Assessment	EG0001 affected42 at risk EG0010 affected41 at risk EG0020 affected41 at risk EG003
Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 16.0	Non-systematic Assessment	EG0001 affected42 at risk EG0013 affected41 at risk EG0020 affected41 at risk EG003
Muscle Strain	Injury, poisoning and procedural complications	MedDRA Version 16.0	Non-systematic Assessment	EG0000 affected42 at risk EG0010 affected41 at risk EG0021 affected41 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 16.0	Non-systematic Assessment	EG0001 affected42 at risk EG0011 affected41 at risk EG0020 affected41 at risk EG003
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 16.0	Non-systematic Assessment	EG0000 affected42 at risk EG0013 affected41 at risk EG0021 affected41 at risk EG003
Headache	Nervous system disorders	MedDRA Version 16.0	Non-systematic Assessment	EG0001 affected42 at risk EG0013 affected41 at risk EG0024 affected41 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Non-systematic Assessment	EG0001 affected42 at risk EG0011 affected41 at risk EG0020 affected41 at risk EG003
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Non-systematic Assessment	EG0000 affected42 at risk EG0010 affected41 at risk EG0020 affected41 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA Version 16.0	Non-systematic Assessment	EG0004 affected42 at risk EG0011 affected41 at risk EG0020 affected41 at risk EG003
Hypertension	Vascular disorders	MedDRA Version 16.0	Non-systematic Assessment	EG0001 affected42 at risk EG0011 affected41 at risk EG0020 affected41 at risk EG003

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama		United States

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins

ID	Title	Description
BG000	Placebo	Participants received placebo matched to CNTO1959 subcutaneous injection at Week 0, Week 4, Week 8 then 100 mg CNTO1959 at Week 16 and once every 8 weeks thereafter through Week 40.
BG001	CNTO1959 5 mg	Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
BG002	CNTO1959 15 mg	Participants received CNTO1959 15 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
BG003	CNTO1959 50 mg	Participants received CNTO1959 50 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
BG004	CNTO1959 100 mg	Participants received CNTO1959 100 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
BG005	CNTO1959 200 mg	Participants received CNTO1959 200 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
BG006	Adalimumab	Participants received Adalimumab 80 mg subcutaneous injection at Week 0, 40 mg at Week 1 and once every other week thereafter through Week 39.
BG007	Total	Total of all reporting groups